Diabetes Homeless Medication Support Single Arm Treatment Development Trial
NCT ID: NCT04678284
Last Updated: 2023-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2021-03-24
2022-03-24
Brief Summary
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Detailed Description
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This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the D-Homes treatment manual through test cases (n=15). With a hypothesis that the D-Homes manual and study procedures will be feasible and acceptable to DH as measured by self-report and post-treatment interview.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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D-Homes intervention
Behavioral treatments by a diabetes wellness coach as defined below.
Diabetes Homeless Medication Support (D-Homes)
There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resource and care coordination. The coach will also provide brief diabetes education as needed.
Interventions
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Diabetes Homeless Medication Support (D-Homes)
There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resource and care coordination. The coach will also provide brief diabetes education as needed.
Eligibility Criteria
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Inclusion Criteria
2. English-speaking
3. Homelessness by federal definition in the last 12 mo.
4. Self-reported diagnosis of type 2 diabetes, later verified in medical record
5. Plan to stay in local area or be reachable by phone for the next 16 weeks
6. Willingness to work on medication adherence and diabetes self-care
7. HbA1c \>/= 7.5%
Exclusion Criteria
2. Active psychosis or intoxication precluding ability to give informed consent
3. Pregnant or lactating females.
4. Patients who choose to opt out of research.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Minnesota
OTHER
Hennepin Healthcare Research Institute
OTHER
Responsible Party
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Locations
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Hennepin Healthcare
Minneapolis, Minnesota, United States
Countries
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References
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Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HHRI-DHomes
Identifier Type: -
Identifier Source: org_study_id
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